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Myriad publishes myPath Melanoma pivotal validation study

Myriad Genetics, Inc. has announced the Journal of Cutaneous Pathology published data from a pivotal clinical validation study that showed the myPath Melanoma test is highly effective at differentiating benign skin moles from malignant melanoma with greater than 90 percent diagnostic accuracy.1 Melanoma is the most dangerous type of skin cancer and more than 76,000 new cases of melanoma are diagnosed each year in the United States.

“Conventional methods of differentiating benign moles from melanoma are effective for many cases, but there is no one-size-fits-all approach. About 15 percent of cases are difficult or impossible to diagnose using standard tools, which can lead to undesirable outcomes such as untreated melanoma, unnecessary treatment or psychological distress,” said Loren Clarke, M.D., medical director for Dermatology at Myriad. “myPath Melanoma is a powerful new molecular diagnostic test that analyzes genetic information inside skin cells to help us understand the biology of a patient’s skin lesion and objectively differentiate benign moles from potentially lethal melanoma.”

The published study describes the discovery, verification and clinical validation of the myPath Melanoma test, which was designed to differentiate benign moles from malignant melanoma. The myPath Melanoma test was developed using a verification cohort of 464 patient samples and was validated in a separate independent study with 437 patient samples from leading academic medical centers in the United States. In both the verification and validation studies, the myPath Melanoma test demonstrated a greater than 90 percent diagnostic accuracy, making it the most accurate molecular diagnostic test developed to date for melanoma. These clinical findings validate the performance, objectivity and reliability of the myPath Melanoma test for clinical use to improve the diagnosis of melanoma.

“The myPath Melanoma study results confirm the test’s potential to more objectively differentiate between benign lesions and malignant melanoma than current evaluation practices,” said Sancy Leachman. M.D., Ph.D., one of the study’s lead investigators and director of the Melanoma Research Program, Knight Cancer Institute, Oregon Health & Science University. “The study results validate the promise of molecular diagnostics in improving the precision of cancer treatment.”


[1] Clinical validation of a gene expression signature that differentiates benign nevi from malignant melanoma, Clarke L, Warf M, Flake D, et al., Journal of Cutaneous Pathology, DOI: 10.1111/cup.12475, published online 2 March 2015.

Source: Myriad Genetics